Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted ma
FDA device recall Z-0491-2010 · posted 2009-12-07 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
- Action taken
- Alphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information. The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the company at 1-800-922-1356.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 56
- Distribution
- AZ, CA, FL, TX
- Date initiated
- 2008-11-03
- Date posted
- 2009-12-07
- Date terminated
- 2009-12-08
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K042673) | Alphatec/Nexmed | 2004-10-27 |